FDA product code · Dental

Clasp, Preformed

Name: FDA decisions, review times, recalls and adverse event reports for product code EHP
Creator: 510(k) Report

EHPClass I21 CFR 872.3285510(k) exempt8 decisions since 19800 recalls

FDA lists EHP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 8 FDA decisions since 1980. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, dental panel

Twenty years of EHP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · EHP

FDA has decided no EHP device since 2007.

Median 510(k) review, days · EHP

Too few EHP 510(k)s in any year since 2007 to give a median.

Recalls per year · EHP

No recall names EHP since 2007.

Adverse event reports per year · EHP

No MAUDE report names EHP since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — EHP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EHP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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Other codes under 21 CFR 872.3285.

EJW Clasp, Wire

Clasp, Preformed

What has FDA decided in EHP lately?

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